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The Bone & Joint Journal
Vol. 106-B, Issue 5 | Pages 468 - 474
1 May 2024
d'Amato M Flevas DA Salari P Bornes TD Brenneis M Boettner F Sculco PK Baldini A

Aims. Obtaining solid implant fixation is crucial in revision total knee arthroplasty (rTKA) to avoid aseptic loosening, a major reason for re-revision. This study aims to validate a novel grading system that quantifies implant fixation across three anatomical zones (epiphysis, metaphysis, diaphysis). Methods. Based on pre-, intra-, and postoperative assessments, the novel grading system allocates a quantitative score (0, 0.5, or 1 point) for the quality of fixation achieved in each anatomical zone. The criteria used by the algorithm to assign the score include the bone quality, the size of the bone defect, and the type of fixation used. A consecutive cohort of 245 patients undergoing rTKA from 2012 to 2018 were evaluated using the current novel scoring system and followed prospectively. In addition, 100 first-time revision cases were assessed radiologically from the original cohort and graded by three observers to evaluate the intra- and inter-rater reliability of the novel radiological grading system. Results. At a mean follow-up of 90 months (64 to 130), only two out of 245 cases failed due to aseptic loosening. Intraoperative grading yielded mean scores of 1.87 (95% confidence interval (CI) 1.82 to 1.92) for the femur and 1.96 (95% CI 1.92 to 2.0) for the tibia. Only 3.7% of femoral and 1.7% of tibial reconstructions fell below the 1.5-point threshold, which included the two cases of aseptic loosening. Interobserver reliability for postoperative radiological grading was 0.97 for the femur and 0.85 for the tibia. Conclusion. A minimum score of 1.5 points for each skeletal segment appears to be a reasonable cut-off to define sufficient fixation in rTKA. There were no revisions for aseptic loosening at mid-term follow-up when this fixation threshold was achieved or exceeded. When assessing first-time revisions, this novel grading system has shown excellent intra- and interobserver reliability. Cite this article: Bone Joint J 2024;106-B(5):468–474


Orthopaedic Proceedings
Vol. 106-B, Issue SUPP_16 | Pages 82 - 82
19 Aug 2024
Courington R Ferreira R Shaath MK Green C Langford J Haidukewych G
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When treating periprosthetic femur fractures (PPFFs) around total hip arthroplasty (THA)], determining implant fixation status preoperatively is important, since this guides treatment regarding ORIF versus revision. The purpose of this study was to determine the accuracy of preoperative implant fixation status determination utilizing plain films and CT scans. Twenty-four patients who underwent surgery for Vancouver B type PPFF were included in the study. Two joint surgeons and two traumatologists reviewed plain films alone and made a judgment on fixation status. They then reviewed CT scans and fixation status was reassessed. Concordance and discordance were recorded. Interobserver reliability was assessed using Kendall's W and intraobserver reliability was assessed using Cohen's Kappa. Ultimately, the “correct” response was determined by intraoperative findings, as we routinely test the component intraoperatively. Fifteen implants were found to be well-fixed (63%) and 9 were loose. Plain radiographs alone predicted correct fixation status in 53% of cases. When adding the CT data, the correct prediction only improved to 55%. Interestingly, concordance between plain radiographs and CT was noted in 82%. In concordant cases, the fixation status was found to be correct in 55% of cases. Of the 18% of cases with discordance, plain films were correct in 43% of cases, and the CT was correct in 57%. Interobserver reliability demonstrated poor agreement on plain films and moderate agreement on CT. Intraobserver reliability demonstrated moderate agreement on both plain films and CT. The ability to determine fixation status for proximal PPFFs around uncemented femoral components remains challenging. The addition of routine CT scanning did not significantly improve accuracy. We recommend careful intraoperative testing of femoral component fixation with surgical dislocation if necessary, and the surgeon should be prepared to revise or fix the fracture based on those findings


Orthopaedic Proceedings
Vol. 101-B, Issue SUPP_5 | Pages 94 - 94
1 Apr 2019
Peterson M Najmabadi Y Robinson R
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INTRODUCTION. Additive manufacturing (3D printing) is used to create porous surfaces that promote bone ingrowth in an effort to improve initial stability and optimize long-term biological fixation. The acetabular cup that was studied is manufactured with titanium alloy powder via electron beam melting. Electron beam melting integrates the porous and solid substrate rather than sintering a porous coating to a solid surface. The 3D-printed acetabular cup's high surface coefficient of friction (up to 1.2), combined with its geometry, creates a predictable press-fit in the acetabulum, improving initial mechanical stability and ultimately leading to reproducible biologic fixation. The objective of this study was to evaluate the early clinical outcomes and implant fixation of this 3D-printed acetabular cup in total hip arthroplasty (THA). METHODS. Four hundred twenty-eight subjects from 8 US and international research sites underwent primary THA with the 3D-printed acetabular cup. All sites received IRB approval prior to conducting the study, and all participants signed the informed consent. Screw usage and number used during surgery were used as a surrogate measurement for initial implant fixation. Clinical performance outcomes included pre- and post-operative Harris Hip Scores (HHS) and Oxford Hip Scores (OHS), patient satisfaction, and revision assessment. 215 patients had a minimum 1-year post-operative follow-up visit. Student t-tests were used to identify significant mean differences (p<0.05). RESULTS. Acetabular screws were used in 206 of 428 cases (48.1%); 85.9% used 1 screw, 12.6% used 2 screws, and 1.5% used 3 screws. For patients with a 1-year post-operative visit, the HHS improved by 49.8 points to 91.9 from 42.1, and the OHS improved by 27.7 points to 44.4 from16.7. Patient satisfaction scores at the 1-year post-operative visit were 9.7±0.7 (n=94). There was no significant difference between genders with regard to BMI, the 1-year post-operative HHS, OHS, or patient satisfaction scores. However, the males were significantly younger (59.8 vs. 62.9 years) and had significantly higher pre-operative HHS (45.7 vs. 37.9) and OHS scores (17.8 vs. 15.3). There were 9 revisions reported. DISCUSSION. For initial implant fixation, compared to a similar, non-3D-printed acetabular cup in the same product line, the 3D-printed cup used significantly fewer screws per case (n=1 for 85.9% cases vs. n=2 for 85.7% of cases) in a fewer percentage of cases (48.1% vs. 70.4%), suggesting greater initial stability and “scratch fit”. The 3D-printed acetabular cup also displayed positive early clinical results as evidenced by the pronounced improvement in clinical outcome scores from the pre-operative visit to the 1-year post-operative visit. These 1-year improvements are better than moderate clinically important improvements reported in the literature (40.1 points for HHS). Patient satisfaction scores were also excellent (9.7/10). There were nine revisions; however, four of these were due to patient falls and one was due to infection. SIGNIFICANCE. The 3D-printed acetabular cup evaluated in this study demonstrated improved implant fixation and positive early clinical outcomes for THA


Bone & Joint Research
Vol. 10, Issue 8 | Pages 488 - 497
10 Aug 2021
Cleemann R Sorensen M West A Soballe K Bechtold JE Baas J

Aims. We wanted to evaluate the effects of a bone anabolic agent (bone morphogenetic protein 2 (BMP-2)) on an anti-catabolic background (systemic or local zoledronate) on fixation of allografted revision implants. Methods. An established allografted revision protocol was implemented bilaterally into the stifle joints of 24 canines. At revision surgery, each animal received one BMP-2 (5 µg) functionalized implant, and one raw implant. One group (12 animals) received bone graft impregnated with zoledronate (0.005 mg/ml) before impaction. The other group (12 animals) received untreated bone graft and systemic zoledronate (0.1 mg/kg) ten and 20 days after revision surgery. Animals were observed for an additional four weeks before euthanasia. Results. No difference was detected on mechanical implant fixation (load to failure, stiffness, energy) between local or systemic zoledronate. Addition of BMP-2 had no effect on implant fixation. In the histomorphometric evaluation, implants with local zoledronate had more area of new bone on the implant surface (53%, p = 0.025) and higher volume of allograft (65%, p = 0.007), whereas implants in animals with systemic zoledronate had the highest volume of new bone (34%, p = 0.003). Systemic zoledronate with BMP-2 decreased volume of allograft by 47% (p = 0.017). Conclusion. Local and systemic zoledronate treatment protects bone at different stages of maturity; local zoledronate protects the allograft from resorption and systemic zoledronate protects newly formed bone from resorption. BMP-2 in the dose evaluated with experimental revision implants was not beneficial, since it significantly increased allograft resorption without a significant compensating anabolic effect. Cite this article: Bone Joint Res 2021;10(8):488–497


Orthopaedic Proceedings
Vol. 92-B, Issue SUPP_I | Pages 141 - 141
1 Mar 2010
Choi D Yoon YS Hwang DS
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The cemented and cementless implant fixations are popular in orthopaedic arthroplasty. However, these implant fixations have some problems such as cement failure, wear debris, stress shielding, revision and so on. To overcome these problems, we are developing a new concept of buffered implant fixation which uses a bone-friendly buffer between the implant and the bone. In this study, we performed a finite element analysis to evaluate the buffered implant fixation in comparison with cemented and cementless implant fixations in mechanical aspects. In addition, we investigated the effect of buffer taper angle to the stress distribution in the buffered implant fixation. Three-dimensional FEA of the cemented, cementless and buffered fixation were performed using the ABAQUS program. In these FEA, the ‘standardized femur’, which is the composite femur model supplied by Pacific Research Lab., was used as the bone model and the CPT stem and the Versys Fibermetal Midcoat stem were modeled for the cemented fixation and the cementless fixation, respectively. These three-dimensional models were meshed using the tetrahedral elements with 4 nodes (C3D4) and the additional contact definitions. The buffered implant fixation is similar with the polished cemented fixation except the material between the implant and the bone. The polyetheretherketone (PEEK) was selected as the buffer material. Also, several taper angles of buffer were simulated to change the stress distributions in the buffered fixation. The external load three times of mean body weight (74.3 kg) was cyclically loaded at the femoral head with the angle of 20° in adduction and 6° in flexion while the distal end of femur was fixed. In the buffered implant fixation, the taper-locked effects were observed. The buffered fixation had greater cyclic compression for the bone compared to the cemented fixation. Also, the failure probability of the buffer in the buffered fixation was less than that of the cement in the cemented fixation. The risk factors in the buffer were 0.148 for the tension and 0.176 for the compression while, the risk factors of cement in the polished cemented implant fixation were over than 1. Moreover, the buffered fixation had widely distributed compression compared to the cementless fixation and the stress distribution could be modified easily to change the taper angle of buffer. The FEA results showed that the buffered implant fixation would provide an appropriate mechanical environment


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXXVII | Pages 54 - 54
1 Sep 2012
Barckman J Baas J Sorensen M Bechtold J Lange J Soballe K
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Introduction. Hip and knee arthroplasty present surgeons with difficult bone loss. In these cases the use of morselized allograft is a well established way of optimizing early implant fixation. In revisions, the surgical field is potentially infected. The use of allograft bone creates a “dead space” in which the immune system has impaired access, and even a small amount of bacteria may therefore theoretically increase the risk of infection. In vivo studies have shown that allograft bone is suitable as a vehicle of local antibiotic delivery. We hypothesized that the allograft bone could be used as a local antibiotic delivery vehicle without impairing the implant fixation, tested by mechanical push-out. Material and Methods. Following approval of the Institutional Animal Care and use Committee we implanted a cylindrical (10×6 mm) porous-coated Ti implant in each distal femur of 12 dogs observed for 4 weeks. The implants were surrounded by a circumferential gap of 2.5 mm impacted with a standardized volume of morselized allograft. In the two intervention groups, 0.2ml tobramycin solution of high (800mg/ml) and low (200mg/ml) concentration was added to the allograft, respectively. In the control group 0.2ml saline was added to the allograft. ANOVA-test was applied followed by paired t-test where appropriate. A p-value < 0,05 was considered statistically significant. Results. The impregnation of allograft bone revealed a relative decrease in biomechanical fixation. The decrease was higher in the high dose group than in the low dose group. The most extreme difference was a decrease in strength by 18% (P = 0,511), stiffness 15% (P = 0,135) and energy absorption 27% (P = 0,784). Conclusion. The result shows a trend towards a decrease in implant fixation correlating with the antibiotic concentration. Although the results are not statistically significant the use of antibiotic impregnation should be used with caution until further reaserch has been conducted


Orthopaedic Proceedings
Vol. 103-B, Issue SUPP_2 | Pages 63 - 63
1 Mar 2021
Halcrow B Wilcox R Brockett C
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Abstract. Introduction. Ankle arthritis is estimated to affect approximately 72 million people worldwide. Treatment options include fusion and total ankle replacement (TAR). Clinical performance of TAR is not as successful as other joint replacement and failure is poorly understood. Finite element analysis offers a method to assess the strain in bone implanted with a TAR. Higher strain has been associated with microfracture and alters the bone-implant interface. The aim of this study was to explore the influence of implant fixation on strain within the tibia when implanted with a TAR through subject-specific models. Methods. Five cadaveric ankles were scanned using a Scanco Xtreme CT. The Tibia and Talus were segmented from each scan and virtually implanted with a Zenith TAR (Corin, UK) according to published surgical technique. Patient specific models were created and run at five different positions of the gait cycle corresponding to peak load and flexion values identified from literature. Bone material properties were derived from CT greyscale values and all parts were meshed with linear tetrahedral elements. The implant-bone interface was adjusted to fully-fixed or frictionless contact, representing different levels of fixation post-surgery. Strain distributions around the tibial bone fixation were measured. Results. Initial results showed clear differences in strain distributions both between different ankle specimens and fixation levels, with highest strain occurring within the bone at the tip of the tibial stem. Frictionless contact gave higher strain outputs than fully-fixed for all specimens with a range 0.12–0.3% and 0.07%–0.13% respectively. Conclusions. In all specimens, strain was higher in the frictionless contact, which may be considered representative of no bony ingrowth, highlighting fixation may be a critical factor in TAR failure. Differences observed between specimens highlights that TAR may not be a suitable intervention for all patients, due to variation in bone quality and anatomy. Declaration of Interest. (b) declare that there is no conflict of interest that could be perceived as prejudicing the impartiality of the research reported:I declare that there is no conflict of interest that could be perceived as prejudicing the impartiality of the research project


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_34 | Pages 106 - 106
1 Dec 2013
Kluess D Ruther C Gabler C Mittelmeier W Bader R
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Clinically applied methods of assessing implant fixation and implant loosening are of sub-optimal precision, leading to the risk of unsecure indication of revision surgery and late recognition of bone defects. Loosening diagnosis involving measuring the eigenfrequencies of implants has its roots in the field of dentistry. The changing of the eigenfrequencies of the implant-bone-system due to the loosening state can be measured as vibrations or structure-borne sound. In research, vibrometry was studied using an external shaker to excite the femur-stem-system of total hip replacements and to measure the resulting frequencies by integrated accelerometers or by ultrasound. Since proper excitation of implant components seems a major challenge in vibrometry, we developed a non-invasive method of internal excitation creating an acoustic source directly inside the implant. In the concept proposed for clinical use, an oscillator is integrated in the implant, e.g. the femoral stem of a total hip replacement. The oscillator consists of a magnetic or magnetisable spherical body which is fixed on a flat steel spring and is excited electromagnetically by a coil placed outside the patient. The oscillator impinges inside the implant and excites this to vibrate in its eigenfrequency. The excitation within the bending modes of the implant leads to a sound emission to the surrounding bone and soft tissue. The sound waves are detected by an acoustic sensor which is applied on the patient's skin. Differences in the signal generated result from varying level of implant fixation. The sensor principle was tested in porcine foreleg specimens with a custom-made implant. Influence of the measurement location at the porcine skin and different levels of fixation were investigated (press-fit, slight loosening, advanced loosening) and compared to the pull-out strength of the implant. Evaluation of different parameters, especially the frequency spectrum resulted in differences of up to 12% for the comparison between press-fit and slight loosening, and 30% between press-fit and advanced loosening. A significant correlation between the measured frequency and the pull-out strength for different levels of fixation was found. Based on these findings, an animal study with sensor-equipped bone implants was initiated using a rabbit model. The implants comprised an octagonal cross-section and were implanted into a circular drill hole at the distal femur. Thereby, definite gaps were realized between bone and implant initially. After implantation, the bone growth around the implant started and the gaps were successively closed over postoperative period. Consequently, since the tests had been started with a loose implant followed by its bony integration, a reverse loosening situation was simulated. In weekly measurements of the eigenfrequencies using the excitation and sensor system, the acoustic signals were followed up. Finally, after periods of 4 and 12 weeks after implantation, the animals were sacrificed and pull-out tests of the implants were performed to measure the implant fixation. The measured implant fixation strengths at the endpoint of each animal trial were correlated with the acoustic signals recorded


Bone & Joint Research
Vol. 13, Issue 6 | Pages 272 - 278
5 Jun 2024
Niki Y Huber G Behzadi K Morlock MM

Aims. Periprosthetic fracture and implant loosening are two of the major reasons for revision surgery of cementless implants. Optimal implant fixation with minimal bone damage is challenging in this procedure. This pilot study investigates whether vibratory implant insertion is gentler compared to consecutive single blows for acetabular component implantation in a surrogate polyurethane (PU) model. Methods. Acetabular components (cups) were implanted into 1 mm nominal under-sized cavities in PU foams (15 and 30 per cubic foot (PCF)) using a vibratory implant insertion device and an automated impaction device for single blows. The impaction force, remaining polar gap, and lever-out moment were measured and compared between the impaction methods. Results. Impaction force was reduced by 89% and 53% for vibratory insertion in 15 and 30 PCF foams, respectively. Both methods positioned the component with polar gaps under 2 mm in 15 PCF foam. However, in 30 PCF foam, the vibratory insertion resulted in a clinically undesirable polar gap of over 2 mm. A higher lever-out moment was achieved with the consecutive single blow insertion by 42% in 15 PCF and 2.7 times higher in 30 PCF foam. Conclusion. Vibratory implant insertion may lower periprosthetic fracture risk by reducing impaction forces, particularly in low-quality bone. Achieving implant seating using vibratory insertion requires adjustment of the nominal press-fit, especially in denser bone. Further preclinical testing on real bone tissue is necessary to assess whether its viscoelasticity in combination with an adjusted press-fit can compensate for the reduced primary stability after vibratory insertion observed in this study. Cite this article: Bone Joint Res 2024;13(6):272–278


Orthopaedic Proceedings
Vol. 94-B, Issue SUPP_XXXVII | Pages 413 - 413
1 Sep 2012
Henriksen S Ding M Overgaard S
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Introduction. The combined incubation of a composite scaffold with bone marrow stromal cells in a perfusion bioreactor could make up a novel hybrid graft material with optimal properties for early fixation of implant to bone. The aim of this study was to create a bioreactor activated graft (BAG) material, which could induce early implant fixation similar to that of allograft. Two porous scaffold materials incubated with cells in a perfusion bioreactor were tested in this study. Methods and Materials. Two groups of 8 skeletally mature female sheep were anaesthetized before aspiration of bone marrow from the iliac crest. For both groups, mononuclear cells were isolated, and injected into a perfusion bioreactor (Millenium Biologix AG, Switzerland). Scaffold granules Ø∼900–1500 μm, ∼88% porosity) in group 1, consisted of hydroxyapatite (HA, 70%) with -tricalcium-phosphate (−TCP, 30%) (Danish Technological Institute, Denmark). The granules were coated with poly-lactic acid (PLA) 12%, in order to increase the mechanical strength of the material (Phusis, France). Scaffold granules Ø∼900–1400 μm, 80% porosity) in group 2 consisted of pure HA/-TCP (Fin Ceramica, Italy). For both groups, cells were incubated in the bioreactor for 2 weeks. Fresh culture medium supplemented with dexamethasone and ascorbic-acid was added every third or fourth day. Porous titanium alloy implants with diameter=length=10mm (Biomet, USA) were inserted bilaterally in each of the distal femurs of the sheep; thus 4 implants in each sheep. The concentric gap (2 mm) surrounding the implant was filled with 1) BAG (autogenous), 2) granules, 3) granules+bone marrow aspirate (BMA, autologous) or 4) allograft. The sheep were euthanized after 6 weeks. Distal femurs were removed and implant-bone samples were divided in two parts. The superficial part was used for mechanical testing and micro-CT scanning, and the profound part for histomorphometry. Push-out tests were performed on an 858 Bionix MTS hydraulic materials testing machine. Shear mechanical properties between implant and newly generated bone were calculated to assess implant fixation. Results were assessed by One-way ANOVA. P-values less than 0.05 were considered significant. Results. One sheep in group 1 had to be euthanized after 4 weeks (excluded). One implant in each group was loosened and could not undergo push-out test (excluded). Group 1: No significant differences regarding failure energy (kJ/m2, p=0.44) or ultimate shear strength (MPa, p=0.17) could be seen. Shear stiffness (MPa) was significantly higher for the allograft group (p=0.04). Group 2: No significant differences regarding failure energy (p=0.11) or shear stiffness (p=0.52) could be seen. Ultimate shear strength was significantly higher for allograft (p=0.04). Results from μ-CT scanning and histomorphometry are pending. Discussion and Conclusion. The present study shows a possible effect of bioreactor activated bone substitute on early implant fixation. We are currently working on bone microarchitecture surrounding implant and histomorphometry. These results will aid in determining if BAG could make up a promising alternative for allograft as bone graft material


Orthopaedic Proceedings
Vol. 92-B, Issue SUPP_I | Pages 96 - 96
1 Mar 2010
Choi D Yoon YS Hwang DS
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We suggested a new concept of buffered implant fixation. It is a cementless fixation using a buffer instead of the cement between the bone and the implant. We investigated the feasibility of the buffered implant fixation using a rat model. In our previous study, we measured the amount of bone around the implant to compare the buffered implant fixation with the cemented fixation. The results showed the difference in change of Bone Volume/Total Volume (BV/TV) with time between the buffered fixation and the cemented fixation. Now, in this study, we are comparing the mechanical interface strength between two fixations. After micro CT scanning, the specimens were used for mechanical push-out test to measure the interface shear strength at the buffer-bone or cement-bone interface. The distal side of the femur was carefully removed to expose the whole distal region of the implant while the proximal side of femur was cut carefully with diamond saw (Metsaw, R& B Inc., Korea) until the proximal end of cement or buffer is exposed. The femur was embedded into a push-out jig with a plaster. The push-out jig was mounted in a material testing machine (KSU-10M, Kyungsung testing machine, Korea) and loaded at a rate of 0.01mm/s. The apparent interface strength was calculated by dividing the peak force by the surface area of the buffer or cement. After 2 weeks, the apparent interface strength is 217.0 ± 280.0(average ± standard deviation) for buffer and 472.4 ± 381.1 for cement; after 4 weeks, 92.9 ± 67.6 and 268.1 ± 197.9; after 12 weeks, 441.9 ± 467.1 and 201.8 ± 132.3, respectively. The buffered fixation showed gain in strength with time while the cemented fixation showed reverse tendency but the interaction by ANOVA was not significant (p=0.125). Even though the excellence of buffer fixation was not clearly confirmed because of small sample size and high variance, the feasibility of the buffer fixation was shown. However, further studies are necessary to improve the buffered implant fixation. To enhance the cell adhesion and biocompatibility, it is necessary to modify the surface of polyetheretherketone (PEEK) such as by plasma treatment or biological coating. Also, an animal test using a higher level animal such as dog or pig is necessary


Bone & Joint Research
Vol. 8, Issue 12 | Pages 604 - 607
1 Dec 2019
Konan S Abdel MP Haddad FS

There is continued debate as to whether cemented or cementless implants should be utilized in particular cases based upon chronological age. This debate has been rekindled in the UK and other countries by directives mandating certain forms of acetabular and femoral component fixation based exclusively on the chronological age of the patient. This editorial focuses on the literature-based arguments to support the use of cementless total hip arthroplasty (THA), while addressing potential concerns surrounding safety and cost-effectiveness.

Cite this article: Bone Joint Res. 2019;8(12):604–607.


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_1 | Pages 109 - 109
1 Jan 2017
van Hamersveld K Valstar E Toksvig-Larsen S
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Whether it is best to retain the posterior cruciate ligament in the degenerated knee, i.e. using a cruciate-retaining (CR) total knee prosthesis (TKP), or to use a more constraint posterior-stabilized (PS) TKP is of debate. There are limited studies comparing the effect of both methods on implant fixation and clinical outcome, leaving it up to the surgeon to base this decision on anything but conclusive evidence. We assessed the effect of two different philosophies in knee arthroplasty on clinical outcome and tibial component migration measured with radiostereometric analysis (RSA), by directly comparing the CR and PS version of an otherwise similarly designed cemented TKP. Sixty patients were randomized and received a Triathlon TKP (Stryker, NJ, USA) of either CR (n=30) or PS (n=30) design. RSA measurements (primary outcome) and clinical scores including the Knee Society Score and Knee injury and Osteoarthritis Outcome Score were evaluated at baseline, at three months postoperatively and at one, two, five and seven years. A linear mixed-effects model was used to analyse the repeated measurements. Both groups showed a similar implant migration pattern, with a maximum total point motion at seven years follow-up of around 0.8 mm of migration (mean difference between groups 95% CI −0.11 to 0.15mm, p=0.842). Two components (one of each group) were considered to have an increased risk of aseptic loosening. Both groups improved equally after surgery on the KSS and KOOS scores and no differences were seen during the seven years of follow-up. No differences in implant migration nor clinical results were seen seven years after cruciate-retaining compared to posterior-stabilized total knee prostheses


Orthopaedic Proceedings
Vol. 88-B, Issue SUPP_II | Pages 320 - 320
1 May 2006
Dhillon R Krebs J Theis J Aebli N
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Cementless implants have gained popularity in modern orthopaedic practice. The type implants and surface characteristics on fixation has been extensively investigated, however there is insufficient data on the effect of the host bone bed status on implant fixation. This study aims to determine if there is a correlation between the fixation strength of cementless press-fit implants and bone mineral density (BMD) of the host bone bed. Implants coated with pure titanium, Hydroxyapatite (HA) with or without Hyaluronic Acid (HY) and implants coated with bone growth factors – Bone Morphogenetic Protein 2 (BMP-2) were inserted into tibiae and femora of 32 skeletally mature ewes (109 implants) for a period of 1, 2 and 4 weeks. Mechanical pull-out testing was performed after each time interval to evaluate the ultimate load of failure (Nmm. −2. ). The BMD (gcm. −3. ) surrounding the implant site was measured using a CT scanner. The mean BMD (S.D.) was 1.515gcm. −3. (0.147gcm. −3. ). The mean (S.D.) mechanical pull-out strength at 1, 2 and 4 weeks was 0.37 (0.31), 3.14 (0.17) and 9.74 (2.31) Nmm. −2. respectively. The overall correlation co-efficient between BMD and pull out strength is 0.31. Early fixation strength of implants is independent of BMD, however, the strength of fixation increases with time in a ‘normal’ sheep population. This suggests that the fixation of implants is dependent on the type of implant and surface coating used rather than the density of the host bone bed


The Journal of Bone & Joint Surgery British Volume
Vol. 90-B, Issue 3 | Pages 400 - 404
1 Mar 2008
Johansson HR Skripitz R Aspenberg P

We have examined the deterioration of implant fixation after withdrawal of parathyroid hormone (PTH) in rats. First, the pull-out force for stainless-steel screws in the proximal tibia was measured at different times after withdrawal. The stimulatory effect of PTH on fixation was lost after 16 days. We then studied whether bisphosphonates could block this withdrawal effect. Mechanical and histomorphometric measurements were conducted for five weeks after implantation. Subcutaneous injections were given daily. Specimens treated with either PTH or saline during the first two weeks showed no difference in the mechanical or histological results (pull-out force 76 N vs 81 N; bone volume density 19% vs 20%). Treatment with PTH for two weeks followed by pamidronate almost doubled the pull-out force (152 N; p < 0.001) and the bone volume density (37%; ANOVA, p < 0.001). Pamidronate alone did not have this effect (89 N and 25%, respectively). Thus, the deterioration can be blocked by bisphosphonates. The clinical implications are discussed


Orthopaedic Proceedings
Vol. 101-B, Issue SUPP_4 | Pages 14 - 14
1 Apr 2019
Van De Kleut M Athwal G Yuan X Teeter M
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Introduction

Total shoulder arthroplasty is the fastest growing joint replacement in recent years, with projected compound annual growth rates of 10% for 2016 through 2021 – higher than those of both the hip and knee combined. Reverse total shoulder arthroplasty (RTSA) has gained particular interest as a solution for patients with irreparable massive rotator cuff tears and failed conventional shoulder replacement, for whom no satisfactory intervention previously existed. As the number of indications for RTSA continues to grow, so do implant designs, configurations, and fixation techniques. It has previously been shown that continuous implant migration within the first two years postoperatively is predictive of later loosening and failure in the hip and knee, with aseptic loosening of implant components a guaranteed cause for revision in the reverse shoulder. By identifying implants with a tendency to migrate, they can be eliminated from clinical practice prior to widespread use. The purpose of this study is to, for the first time, evaluate the pattern and magnitude of implant component migration in RTSA using the gold standard imaging technique radiostereometric analysis (RSA).

Methods

Forty patients were prospectively randomized to receive either a cemented or press-fit humeral stem, and a glenosphere secured to the glenoid with either autologous bone graft or 3D printed porous titanium (Aequalis Ascend Flex, Wright Medical Group, Memphis, TN, USA) for primary reverse total shoulder arthroplasty. Following surgery, partients are imaged using RSA, a calibrated, stereo x-ray technique, at 6 weeks (baseline), 3 months, 6 months, 1 year, and 2 years.

Migration of the humeral stem and glenosphere at each time point is compared to baseline. Preliminary results are presented, with 15 patients having reached the 6-month time point by presentation.


Orthopaedic Proceedings
Vol. 95-B, Issue SUPP_34 | Pages 246 - 246
1 Dec 2013
Bruni D Bragonzoni L Gagliardi M Bontempi M Marcacci M
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The Rizzoli Orthopaedic Institute has been involved in RSA since 1998. During last 25 years, several investigations have been carried on to evaluate both implant fixation and poliethylene deformation in unicompartmental and total knee replacements. Nevertheless, RSA has also been used to investigate the relative micromotions and the kinematic modifications in cadaveric models of ankles with ligamentous injuries. RSA evaluation has demonstrated that in a particular TKR implant, with mobile half-bearings, the threshold for loosening was 1.3° for rotation about the longitudinal axis and 0.5 mm for medio-lateral translation. Moreover, RSA has revealed cold flow to be concentrated in the posterior region of the medial half-bearing. This has lead to further improvement in polyethilene and implant design. RSA has also demonstrated that in all-poly tibial UKR, poliwear does not impair tibial component fixation and that deformation of the all-poly tibial component is strictly correlated to implant loosening. Moreover, RSA has been used to investigate stress-inducible displacement of the tibial component in all-poly UKRs. It has been demonstrated that rotations around the transverse axis of the knee joint are the most common form of stress-inducible displacement, while stress-induced translations are negligible. Moreover, stress-inducible translational displacement has reached significantly higher values for those patients with unexplained painful UKR, despite no sign of loosening on conventional radiographic and standard supine RSA evaluations. Further application of RSA has focused on the kinematic evaluation of poliethilene motion pattern modifications throughout a 3 years follow-up period after a mobile-bearing TKR. Patients have been investigated in weight-bearing conditions and results demonstrated that longitudinal rotations and medio-lateral translations tended to increase at last follow-up, while sagittal translations dod not show any significant modification over time. At present, a new device has been installed at the Istituto Ortopedico Rizzoli. It was specifically designed and made for RSA, static and fluoroscopic. This device can work both in mono- and bi-planar configuration as required by the RSA protocols. Moreover it is able to acquire image stacks in order to study the in-vivo and real time kinematics of a joint. he theoretical biomechanical resolution of a static RSA followup tests is 0.2 mm for translation and 0.3° for rotation. In fluoroscopic configuration the theoretical resolution is 1 mm for translation and 1° for rotations, depending on the used frame rate and on the joint movement speed. A kinematic comparison of different prosthetic designs is currently ongoing, to evaluate different motion patterns under dynamic weight-bearing conditions and to compare them with passive kinematics acquired intra-operatively using a navigation system


The Journal of Bone & Joint Surgery British Volume
Vol. 93-B, Issue 1 | Pages 131 - 139
1 Jan 2011
Daugaard H Elmengaard B Andreassen TT Baas J Bechtold JE Soballe K

Impaction allograft is an established method of securing initial stability of an implant in arthroplasty. Subsequent bone integration can be prolonged, and the volume of allograft may not be maintained. Intermittent administration of parathyroid hormone has an anabolic effect on bone and may therefore improve integration of an implant.

Using a canine implant model we tested the hypothesis that administration of parathyroid hormone may improve osseointegration of implants surrounded by bone graft. In 20 dogs a cylindrical porous-coated titanium alloy implant was inserted into normal cancellous bone in the proximal humerus and surrounded by a circumferential gap of 2.5 mm. Morsellised allograft was impacted around the implant. Half of the animals were given daily injections of human parathyroid hormone (1–34) 5 μg/kg for four weeks and half received control injections. The two groups were compared by mechanical testing and histomorphometry. We observed a significant increase in new bone formation within the bone graft in the parathyroid hormone group. There were no significant differences in the volume of allograft, bone-implant contact or in the mechanical parameters.

These findings suggest that parathyroid hormone improves new bone formation in impacted morsellised allograft around an implant and retains the graft volume without significant resorption. Fixation of the implant was neither improved nor compromised at the final follow-up of four weeks.


Orthopaedic Proceedings
Vol. 102-B, Issue SUPP_1 | Pages 32 - 32
1 Feb 2020
Maag C Peckenpaugh E Metcalfe A Langhorn J Heldreth M
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Introduction

Aseptic loosening is one of the highest causes for revision in total knee arthroplasty (TKA). With growing interest in anatomically aligned (AA) TKA, it is important to understand if this surgical technique affects cemented tibial fixation any differently than mechanical alignment (MA). Previous studies have shown that lipid/marrow infiltration (LMI) during implantation may significantly reduce fixation of tibial implants to bone analogs [1]. This study aims to investigate the effect of surgical alignment on fixation failure load after physiological loading.

Methods

Alignment specific physiological loading was determined using telemetric tibial implant data from Orthoload [2] and applying it to a validated finite element lower limb model developed by the University of Denver [3]. Two high demand activities were selected for the loading section of this study: step down (SD) and deep knee bend (DKB). Using the lower limb model, hip and ankle external boundary conditions were applied to the ATTUNE® knee system for both MA and AA techniques. The 6 degree of freedom kinetics and kinematics for each activity were then extracted from the model for each alignment type. Mechanical alignment (MA) was considered to be neutral alignment (0° Hip Knee Ankle Angle (HKA), 0° Joint Line (JL)) and AA was chosen to be 3° varus HKA, 5° JL. It is important not to exceed the limits of safety when using AA as such it is noted that DePuy Synthes recommends staying within 3º varus HKA and 3º JL. The use of 5º JL was used in this study to account for surgical variation [Depuy-Synthes surgical technique DSUS/JRC/0617/2179].

Following a similar method described by Maag et al [1] ATTUNE tibial implants were cemented into a bone analog with 2 mL of bone marrow in the distal cavity and an additional reservoir of lipid adjacent to the posterior edge of the implant. Tibial implant constructs were then subjected to intra-operative ROM/stability evaluation, followed by a hyperextension activity until 15 minutes of cement curing time, and finally 3 additional ROM/stability evaluations were performed using an AMTI VIVO simulator. The alignment specific loading parameters were then applied to the tibial implants using an AMTI VIVO simulator. Each sample was subjected to 50,000 DKB cycles and 120,000 SD cycles at 0.8 Hz in series; approximating 2 years of physiological activity. After physiological loading the samples were tested for fixation failure load by axial pull off.


Orthopaedic Proceedings
Vol. 99-B, Issue SUPP_2 | Pages 51 - 51
1 Jan 2017
Ramos A Mesnard M
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The Temporomandibular joint (TMJ) is a complex and important joint for daily activities, and the alloplastic implant is recommended as the best solution, after repeated surgeries, failed autogenous grafts, highly inflammatory metabolic arthritis, fibrous or bony ankyloses. Some complications in total TMJ replacement are associated with implant design, screw fixation failure, implant displacement, fibrous tissue formation, (Speculand, et al. 2000). Some numeric studies evaluate the number of screws needed to guarantee the good fixation and suggest a minimum of three (Ramos et al. 2015), but is a controversy conclusion. The Biomet Microfixation TMJ stock prosthesis, Jacksonville, FL, USA is one of the three or four in the market. Clinical studies published by this device between 2005 and 2015 indicate a success rate of around 84 to 91% with improvements in mouth opening, a decrease in pain score and improved quality of life. The present study analyses experimentally the load transfer of this device. The intact, clean cadaveric ramus was instrumented with four rosettes model (KFG-1-120-D17-11 L3M2S, by Kywoa Electronic Instruments Co™, Japan), one in lateral region, two in lateral region and one in lingual face. The condyle was loaded with the temporal reaction; the load was applied constant velocity of 1mm/min in three continuum phases and with three stops at 100N, 200N and 300N. Next, the Biomet microfixation implant was fixed to the same cadaveric mandibular ramus after resection. The implant was 50mm in length. It was fixed with five 6AL/4V Titanium self-tapping screws with 2.7mm diameter were long enough to establish a bi-cortical support. The screws were screwed into the bone with a torque-screwdriver a constant torque of 0.2Nm. The same rosettes were analyzed before and after implantation and the mandible displacement two. The experimental results for the mandibular ramus present a linear behavior up to 300N load in condyle, with the Biomet implant influencing strain distribution; the maximum influence was near the implant (rosette #4) is around 59%. The average vertical displacement of the mandibular ramus (300N) was measured by machine: 1.18 (±0.02) mm for the intact mandibular ramus and 1.21 (±0.02) mm for the implanted one, which represents a 2.8% differences between the experimental models and reduce of stiffness. The maximum principal strain deformation was observed in the rosette #3 with 1360µε more 20% than the intact mandible for 300N of reaction. The experimental results show that the Biomet TMJ mandibular ramus implant changes the load transfer in the ramus, compared to the intact, with its strain shielding effect. The results indicate the minimum number of screws is three to guarantee a good load transfer but the surface preparation of condyle presents an important factor